The Study On Quality Control Of The Antineoplastic Innovative Drug Of The PD And Its Tablet

2-indolinone derivative [3-(3-pyridylmethylidene)-2-indolinone, PD], is a kind of indolin-2-one derivatives, which has a unique and powerful antioxidant, anti-inflammatory effects and has develope into a huge potential antitumor drugs synthesize in preliminary pharmacological studies.The drug quality control and stability study needs to be done belong to the medicine development stage of the work( Preclinical studies), which includes two parts of pharmaceutical raw materials and preparations. In the whole process of drug development, drug quality comprehensive analysis, to strengthen the control on the quality of the drug, to ensure the smooth pre clinical and clinical research effectively provided the strongest support, and to effectively provided the strongest support in real marketed drugs and protecting the people’s drug safety.This paper is divided into two parts, the first part: quality control and stability of PD API; the second part: quality standard research of PD tablets.1.Study on quality control and stability of PD API1The quality control research of PD APITechnical specifications of this part is basis on "Chinese Pharmacopoeia" quality standards and new drug research PD quality standards for research. The effects of traits, physical constants, identification and other projects, related substances, organic residual solvent testing method for the determination and synthetic materials have been studied, which developed for the determination method PD ethanol, piperidine two kinds of residual organic solvent, identified PD check related substances by HPLC, establish a HPLC method for the determination of drug content and drug synthesis of raw materials.2The stability study research of PD APIThis part of the paper pharmaceutical stability testing guidelines for PD stability studies, including stress testing, accelerated testing and long term test. Appearance of the stability of the samples, UV absorption, the melting point of the analysis, principal component content and related substances. It was found that PD high temperature, high humidity, light conditions are more sensitive about the content of the substance, suggesting that the sample was not suit to a high temperature, high humidity, bright light conditions of preservation. Through accelerated test showed that: the sample 40℃, can be stable under the conditions of 75% humidity nine months. Through long-term test showed that: the samples at 25℃, 60% humidity conditions can be stable nine months, long-term trials currently ongoing.2.The study on quality standard research of PD tabletIn this paper, the external shape of the tablet, the tablet weight difference, dissolution and content uniformity, had been examined. Dissolution test examined under dissolution medium speed and dissolution sampling time and other conditions, the dissolution conditions is that: The paddle method, 0.1mol /ml of hydrochloric acid dissolution medium(900ml), speed 50r/min, respectively, at 5, 10, 20, 30, 45 min sampling time points. Through tablet content uniformity and dissolution profile test to evaluate the consistency of the quality of the tablets, the results show that tablets had high quality consistency by high temperature, high humidity and strong light changes investigated under experimental conditions factor tablets, the results shows PD tablets under these three conditions have been stable.